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Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT00139360
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : August 27, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To determine the efficacy as measured by objective tumor response of first-line treatment of metastatic melanoma with bevacizumab monotherapy

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Drug: Bevacizumab Phase 2

Detailed Description:

In Norway, cutaneous malignant melanoma is the second most frequent and the most frequent cancer type in middle-aged (30-54 years) females and males, respectively, and the incidence has six-doubled during the last 30 years. Median survival for patients with metastatic melanoma is 6 months.

Many agents have been investigated for anti-tumor effect in melanoma, but there is no accepted standard therapy. Biochemotherapy, combining cytotoxic drugs with Interleukin-2 or Interferon alpha, has not been shown to be superior to single agent Dacarbazine (DTIC), which is regarded to be the most active agent. Other biological approaches like vaccination are currently under investigation, but still no efficient treatment for metastatic melanoma is available. DTIC induces objective remission in 20% of the patients, but without significant impact on survival.

The need of a new and effective treatment for the group of melanoma patients is urgently needed. This will be the first study to assess response rates of bevacizumab monotherapy in first line treatment of metastatic melanoma. In addition there will be a major focus on the identification of predictive biomarkers of bevacizumab efficacy.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma and Predictive Value of Angiogenic Markers
Study Start Date : May 2005
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Active drug
Drug: Bevacizumab
Anti angiogenesis treatment


Outcome Measures

Primary Outcome Measures :
  1. Clinical Response rates [ Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years. ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years. ]
  2. Overall survival [ Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years. ]
  3. Safety data [ Time Frame: Evaluated by consultations every 12 weeks, later every 6 monts. Up to 10 years. ]
    CTCAEv2 side effects


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

LEVEL A (second line): after confirmed progression on standard first line treatment with dacarbazine.

LEVEL B (first line): when objective clinical response is observed in LEVEL A, patients will be included for first line treatment with bevacizumab

Inclusion Criteria:

  • Histologically confirmed metastatic (unresectable) melanoma and with progressive disease
  • WHO performance status 0-2
  • Age >18 years
  • Able to undergo outpatient treatment
  • Patients must have clinically and/or radiographically documented measurable disease according to RECIST criteria
  • At least 4 weeks since adjuvant interferon alpha
  • Recovered from prior chemotherapy
  • Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start. Biopsy or fine needle aspiration within 5 days prior to study treatment start. Central venous line placement must be inserted at least 5 days prior to treatment start.
  • Minimum required laboratory data:

Hematology: absolute granulocytes > 1.0 x 109/L platelets > 100 x 109/L Biochemistry: bilirubin < 1.5 x upper normal limit serum creatinine within normal limits INR < 1.5

  • Before patient registration/randomization, written informed consent must be given according to national and local regulations.

Exclusion Criteria:

  • No pregnant or lactating patients can be included
  • No prior interferon alpha or IL-2 for metastatic disease
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • No clinical evidence of coagulopathy
  • No brain metastases
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No history of thrombosis
  • No full-dose oral coumarin-derived anticoagulants (INR>1.5) or heparin, thrombolytic agents, or chronic, daily treatment with aspirin (>325 mg/day)
  • No non-steroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
  • No uncontrolled hypertension
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139360


Locations
Norway
Department of Oncology, Haukeland University Hospital
Bergen, Norway, 5020
Sponsors and Collaborators
Haukeland University Hospital
Norwegian Cancer Society
Hoffmann-La Roche
Investigators
Principal Investigator: Oddbjorn Straume, MD, PhD Department of Oncology, Haukeland University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oddbjørn Straume, MD PhD, MD PhD, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00139360     History of Changes
Other Study ID Numbers: NSD-11933
94070/013
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents